Sept. 25, 2013 -- Although cigarette use has declined among Americans, regulators face the challenge of communicating the dangers of new tobacco products along with reaching smokers in diverse communities who may not respond to traditional forms of anti-tobacco communication. To address these issues, the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) announced last week that they are awarding a $20 million, five-year grant to fund a center at the University of North Carolina that will study issues related to tobacco prevention communication and regulation.

The UNC Center for Regulatory Research on Tobacco Communication (CRRTC) is one of 14 Tobacco Centers of Regulatory Science (TCORS), which are receiving a total of up to $53 million for tobacco-related research in fiscal year 2013. The new center will be based at UNC Lineberger.

One of the three projects housed at the center is headed by Erin L. Sutfin, Ph.D., assistant professor of social sciences and health policy at Wake Forest Baptist Medical Center, and includes faculty members from the UNC School of Journalism and Mass Communication.

Sutfin's project will focus on effective risk communication of novel tobacco products targeted at adolescents and young adults.

"Although cigarette smoking has declined, use of other tobacco products such as hookahs, flavored cigars and electronic cigarettes, appears to be on the rise, especially among adolescents and young adults. However, many youth don't know or underestimate the risks of using these products," Sutfin said. "The new grant will allow us to develop messages to inform adolescents and young adults about the health risks of using these products in order to help the FDA determine the best ways to educate consumers."

The other two projects will be headed by Adam Goldstein, M.D., M.P.H., director of UNC Tobacco Intervention Programs and Noel Brewer, Ph.D., associate professor of health behavior at UNC's Gillings School of Global Public Health. These studies will look at reinforcing communication with the public about the harmful effects of chemicals found naturally in tobacco and cigarette smoke; and increasing the credibility of risk communications and health risks to audiences from diverse ethnic and LGBT communities.

"The goal is to inform and shape how the FDA regulates tobacco products by doing high impact research that will ultimately help reduce tobacco use," said Kurt Ribisl, Ph.D., program leader of Cancer Prevention and Control Program at the UNC Lineberger, professor of health behavior at UNC's Gillings School of Global Public Health, who will serve as center director.

Despite decades of work to reduce tobacco use in the United States, it continues to be the leading cause of preventable death and disease. A new, first-of-its-kind regulatory science tobacco program, TCORS is designed to generate research to inform the regulation of tobacco products to protect public health. Using designated funds from FDA, TCORS will be coordinated by NIH's Office of Disease Prevention, directed by David M. Murray, Ph.D., and administered by three NIH institutes-the National Cancer Institute, the National Institute on Drug Abuse, and the National Heart, Lung and Blood Institute.

"For the first time, under the Family Smoking Prevention and Tobacco Control Act, the federal government, through the FDA Center for Tobacco Products (CTP), is able to bring science-based regulation to the manufacturing, marketing and distribution of tobacco products," said FDA Commissioner Margaret A. Hamburg, M.D. "The FDA is committed to a science-based approach that addresses the complex public health issues raised by tobacco product regulation." The agency is establishing science and research programs designed to increase understanding of the risks associated with tobacco use.

The TCORS program brings together investigators from across the country to aid in the development and evaluation of tobacco product regulations. Each TCORS application identified a targeted research goal. Taken together, the TCORS sites will increase knowledge across the full spectrum of basic and applied research on tobacco and addiction. The program also provides young investigators with training opportunities to ensure the development of the next generation of tobacco regulatory scientists.

"While we've made tremendous strides in reducing the use of tobacco products in the U.S., smoking still accounts for one in five deaths each year, which is far too many," said NIH Director Francis S. Collins, M.D., Ph.D. "FDA/NIH partnerships like the Tobacco Centers of Regulatory Science keep us focused on reducing the burden and devastation of preventable disease caused by tobacco use."

Comprised of scientists with expertise in fields including epidemiology, behavior, biology, medicine, economics, chemistry, toxicology, addictions, public health, communications, and marketing, the TCORS program is the centerpiece of the FDA/NIH collaboration to foster research relevant to tobacco regulatory science. New research from TCORS will help inform and assess the impact of FDA's prior, ongoing and potential future tobacco regulatory activities implemented by CTP under the direction of Mitch Zeller, JD. In addition, the TCORS investigators will have the flexibility and capacity to begin new research to address issues raised in today's rapidly evolving tobacco marketplace.

The TCORS awards represent a significant investment in federal tobacco regulatory science, including $53 million in the first year and a potential total of more than $273 million over the next five years. TCORS funding may not exceed $4 million in total costs per year per center, and an investigator could request a project period of up to five years.

Designed to generate vital research in seven core areas, as well as ensure innovation in the field, the research supported by this initiative will provide scientific evidence within the following seven FDA tobacco-related research interest areas:

Diversity of tobacco products

Reducing addiction

Reducing toxicity and carcinogenicity

Adverse health consequences

Communications

Marketing of tobacco products

Economics and policies.

TCORS proposals were selected for funding based on their scientific and technical merit as determined by NIH scientific peer review, availability of funds, and relevance of the proposed projects to program priorities.

FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

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